Complications; Cesarean Section
Conditions
Keywords
Spectroscopy, Near-Infrared, Fetal heartrate, Ephedrine, Phenylephrine
Brief summary
The purpose of this study is to determine the impact of phenylephrine versus ephedrine on organ perfusion, in women undergoing caesarean section receiving spinal anaesthesia. The organ perfusion is estimated by measuring the maternal cerebral oxygenation by NIRS(Near-infrared spectroscopy)and the foetal heartrate.
Interventions
DRUGEphedrine
An infusion with a maximum of 3 mg/minute for maximum 60 minutes or if sideeffects develope.
DRUGPhenylephrine
An infusion of maximum 4 mg/hour for maximum 60 minutes.
Sponsors
Rigshospitalet, Denmark
Naestved Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy pregnant women * Over 18 years old * ASA 1-2 * Undergoing elective caesarean section * Height over 160 cm or under 180 cm
Exclusion criteria
* Allergic reactions to ephedrine or phenylephrine * High blood levels of bilirubin * HELPP syndrome * Preeclampsia (pregnancy-induced hypertension) * Non singleton pregnancies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frontal lobe cerebral oxygenation | Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour | Determine the frontal lobe cerebral oxygantion by Near-Infrared Spectroscopy (NIRS),from before induction of spinal anaesthesia to end of surgery. |
| Foetal heartrate | Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour | From before induction of spinal anaesthesia to 15 min after delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial pressure | Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour | The mean arterial pressure is measures from before induction of spinal anaesthesia to end of surgery. |
| Cardiac output | Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour | The cardiac output is measures from before induction of spinal anaesthesia to end of surgery. |
| Umbilical cord pH and Base excess | Blood analysis taken immediately after the the clamping of the umbilical cord, an average of 20 minutes. | The umbilical cord blood analysis for evaluation of the newborn's acid-base status is taken immediately after delivery. It is the most objective way of assessing the fetal metabolic condition at birth. |
Countries
Denmark
Outcome results
None listed